FDAFDA · Alimentos y medicamentos·N.º oficial Z-0974-2019
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.
Publicado el 13 de marzo de 2019 · Inicio del retiro: 8 de febrero de 2019
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Draegar Medical Systems, Inc.
- Distribuidor
- US Nationwide distribution including Puerto Rico.
- Lote
- All software versions, all serial numbers.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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